Software Medical Device Engineer

Stark Pharma; Pleasanton (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Stark Pharma in Pleasanton, CA is seeking a qualified candidate to plan and execute the migration of requirements from legacy tools into new platforms. The role demands a Bachelor's degree in a relevant field and at least 5 years of experience with enterprise requirements management tools in regulated environments. Responsibilities include administering tools, maintaining documentation, and providing training to engineers. This is a 1-year contract position, contributing directly to the medical device development process and ensuring compliance with industry standards.

Qualifications

• Minimum 5 years of experience administering or configuring enterprise requirements management tools.
• Ability to quickly learn and adopt new tools.
• Experience supporting regulated development environments.

Responsibilities

• Plan and execute migration of requirements and related data from legacy tools.
• Administer, configure, and maintain enterprise requirements management tools.
• Develop and maintain a requirements management plan.
• Create and maintain standardized requirements templates.
• Provide training and ongoing support to engineers.

Skills

Requirements migration from legacy tools

Understanding of medical device product development

Excellent verbal and written communication skills

Collaborative work environment skills

Education

Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or related discipline

Tools

DOORS

Jama

Codebeamer

Job description

Responsibilities

• Plan and execute migration of requirements and related data from legacy tools (e.g., DOORS, Jama, Excel, Jira) into new platforms, ensuring data integrity, traceability, and compliance.
• Administer, configure, and maintain enterprise requirements management tools, including hierarchies, templates, workflows, versioning, and baselining in alignment with the quality system.
• Develop and maintain a requirements management plan in collaboration with cross functional teams, defining the overall requirements structure and links to associated design control documents.
• Create and maintain standardized requirements templates, traceability frameworks, and governance models based on quality and regulatory requirements.
• Maintain the requirements database, develop scripts or automation as needed, and support integrations or add in tools to improve usability and efficiency.
• Provide training, documentation, and ongoing support to engineers, serving as the primary functional expert for requirements tools and best practices.

Location: Pleasanton, CA.

The contract is for 1 year.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, Biomedical Engineering, or a related discipline for requirements management.
• A minimum of 5 years with hands on experience administering or configuring enterprise requirements management tools to support regulated development environments (e.g., Codebeamer, DOORS, Jama, or comparable platforms). Ability to quickly learn and adopt new tools is expected.

Requirements

• Hands on experience with requirements migration from legacy tools.
• Strong understanding of medical device product development and design control principles.
• Excellent verbal and written communication skills, with the ability to train and support engineers at all levels.
• Ability to work effectively in a collaborative environment.

Preferred Qualifications

• Experience acting as a tool administrator, configuration owner, or advanced power user in a regulated development environment.
• Experience defining or scaling requirements management frameworks for large or multi team programs.
• Familiarity with medical device development (FDA 21 CFR Part 820) with the ability to configure tools to support compliant workflows.
• Experience supporting software driven, connected, or mobile medical devices.
• Experience with different requirements management or lifecycle tools is valued; strong foundational understanding of requirements structures and traceability is more important than experience with a specific platform.